Studying Immune Status Across Stages of Chronic Hepatitis B
Compares immune status across chronic hepatitis B patients at different clinical stages.
Plain-language title generated from the registry record
Registry title: A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Key facts
- Where
- Beijing, Changchun, Chongqing, Nanjing, and Wuhan, ChinaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT06525909, who can take part
Where in China
- Beijing YouAn HospitalBeijing, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaNot yet recruiting
- Southwest HospitalChongqing, ChinaNot yet recruiting
- Jiangsu Province HospitalNanjing, ChinaNot yet recruiting
- Tongji HospitalWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tongji Hospital
- Trial code
- NCT06525909
- Record updated
- 29 July 2024
- Original description
This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.Read full original descriptionShow less
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.
Inclusion: Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months; Group 1 untreated group fulfils any one of the four natural history types of the Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022; Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (<100 IU/ml).
Exclusion: Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc; previous history of oncology, organ transplantation, etc., history of alcoholism (>30 g/d for men, >20 g/d for women); Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection; Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases; Comorbid serious psychiatric diseases including severe anxiety or depression; Inadequate follow-up time and inadequate clinical/laboratory information; Pregnancy status; Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators; Unwilling to participate in this study.